University Hospitals of Cleveland

Company: University Hospitals of Cleveland
Product: Blood products
Date: 8/19/02

With respect to your response to FDA-483 item #2, you stated that you will institute a computer change. We expect that changes to the computer system should be validated. Please provide documentation of the validation for this new change. Additionally, please explain what actions and/or retraining were taken with this particular phlebotomist.

FDA District: Cincinnati District Office

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